330 Participants Needed

Comprehensive Support Program for Chronic Kidney Disease

Recruiting at 2 trial locations
CM
NC
Overseen ByNicole Clark, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a community-based support program can help individuals with early-stage chronic kidney disease (CKD) improve kidney health, heart health, mental well-being, and diet. Participants will receive either personalized support, grocery e-gift cards, and produce deliveries or just educational materials and usual care. The trial seeks adults diagnosed with early CKD (stage 2 or 3) who visit specified Harris Health clinics and can commit to the program for six months. Individuals with early CKD who can engage with this support may find this trial suitable. As an unphased trial, this study offers a unique opportunity to explore innovative support methods that could enhance overall health and well-being.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that affect potassium metabolism, such as NSAIDs, mineralocorticoid receptor antagonists, and Warfarin. If you are taking these medications regularly, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial are generally safe. Studies have found that using e-gift cards for groceries helps people access healthy foods without harm, and recipients reported positive experiences.

Previous participants found personalized support from a health partner helpful and non-intrusive. This approach is designed to assist without adding stress or causing side effects.

For produce delivery and customized recipes, research suggests that personalized nutrition benefits people with chronic kidney disease. These efforts aim to improve diet quality and have not shown major safety concerns.

Overall, the program components are well-received and focus on improving lifestyle habits, supporting health without introducing new risks.12345

Why are researchers excited about this trial?

Researchers are excited about this comprehensive support program for chronic kidney disease because it goes beyond traditional medical treatments by integrating personalized lifestyle and emotional support into patient care. Unlike standard approaches that mainly focus on medication and dialysis, this program offers personalized practical and emotional support through a dedicated health partner, which can help address the broader needs of patients. Additionally, features like produce delivery with customized recipes and e-gift cards for groceries aim to improve overall nutrition and well-being, which are crucial for managing chronic kidney disease. These unique elements have the potential to enhance patient engagement and improve health outcomes in ways that current treatments might not fully address.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

This trial compares two approaches to supporting individuals with chronic kidney disease (CKD). Participants in one arm will receive a comprehensive intervention, including personalized nutrition through produce deliveries with custom recipes, a dedicated health partner for emotional support and practical advice, and e-gift cards for groceries. Studies have shown that personalized approaches can significantly benefit people with CKD by improving kidney health and overall well-being. Participants in the other arm will receive educational materials. Together, these methods aim to support better kidney health and overall wellness.12367

Who Is on the Research Team?

MK

Maninder Kahlon, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

Adults with early-stage chronic kidney disease (stages 2 or 3), not on dialysis, who speak English or Spanish, can prepare and store food, have SMS access, live in the delivery zone of certain clinics, and have visited one of three partner clinics within the last 18 months. Excludes those with advanced CKD, on Warfarin or certain other medications, recent severe cardiovascular events or procedures.

Inclusion Criteria

I have visited this clinic before, at least once in the last 18 months.
I have chronic kidney disease in stages 2, 3a, or 3b.
I can manage food preparation and storage on my own.
See 5 more

Exclusion Criteria

My doctor has diagnosed me with advanced liver disease.
I haven't had a heart attack, unstable angina, stroke, or TIA in the last 3 months.
You are currently receiving hospice care.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month community-based program including delivery of kidney-friendly produce, grocery store e-gift cards, educational materials, and support from a Health Partner

26 weeks
Regular contact through phone calls and SMS texts

Follow-up

Participants are monitored for changes in kidney injury markers, cardiovascular risk, diet quality, and mental health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • E-gift cards to a grocery store of choice
  • Personalized practical & emotional support through a dedicated health partner
  • Produce delivery + Recipes customized to produce
  • Welcome information (phone or text)
  • Welcome package
Trial Overview The trial is testing a community-based program that includes personalized support from a health partner, produce deliveries with customized recipes, welcome package and information via phone/text, and grocery e-gift cards against usual care. The study measures effects on kidney injury markers like uACR as well as cardiovascular risk factors.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 2: Educational materials + usual careExperimental Treatment2 Interventions
Group II: Arm 1: Intervention + usual careExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Harris Health

Collaborator

Trials
3
Recruited
1,500+

Published Research Related to This Trial

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.
Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.
"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients.Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]
Health care providers involved in produce prescription projects reported operational challenges such as time constraints, difficulties in engaging patients, and barriers to data sharing, which were exacerbated by the COVID-19 pandemic.
Despite these challenges, providers expressed satisfaction with the projects due to positive patient outcomes, including improved food security and clinical results, highlighting the need for dedicated staff and rigorous program evaluation to ensure sustainability and effectiveness.
Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers.Stotz, SA., Budd Nugent, N., Ridberg, R., et al.[2022]
Patients with chronic renal disease should receive comprehensive counseling and educational support to enhance their quality of life.
Healthcare systems need to develop educational programs that utilize existing staff resources, as no additional funding has been allocated for patient education in hospitals.
[Patient education].Tourette-Turgis, C., Isnard-Bagnis, C.[2013]

Citations

Study Details | NCT05970341 | Kidney Health: Eat Well, ...This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the ...
Comprehensive Support Program for Chronic Kidney ...This N/A medical study run by University of Texas at Austin is evaluating whether E-gift cards to a grocery store of choice, Personalized practical ...
IRB Submission - CKD project Factor HealtheGiftcards to a grocery store chosen by the participant among the same available options delivered after the 6 month measurement visit.
A qualitative study of chronic kidney disease knowledge ...The objectives of the study are to understand knowledge among urban, African-American patients diagnosed with CKD and to discover ways they managed their ...
The Effectiveness of Telehealth Intervention on Chronic ...To evaluate the effectiveness of telehealth programs on dietary habits, quality of life, renal function, and blood pressure in adults with chronic kidney ...
Understanding Barriers to Implementing and Managing ...This article reports on research designed to understand food-access barriers in remote First Nations for persons living with stage 4 and 5 CKD/ESRD.
Experiences and perceived outcomes of a grocery gift card ...This study explored programme recipients' and deliverers' experiences and perceived outcomes of accessing or facilitating a grocery gift card (GGC) programme ...
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